Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jun 29;14(2):69-74.
doi: 10.4103/jgid.jgid_281_21. eCollection 2022 Apr-Jun.

A Randomized Controlled Trial of Combined Ivermectin and Zinc Sulfate versus Combined Hydroxychloroquine, Darunavir/Ritonavir, and Zinc Sulfate among Adult Patients with Asymptomatic or Mild Coronavirus-19 Infection

Sireethorn Nimitvilai  1 , Yupin Suputtamongkol  2 , Ussanee Poolvivatchaikarn  1 , Dechatorn Rassamekulthana  3 , Nuttawut Rongkiettechakorn  3 , Anek Mungaomklang  4 , Susan Assanasaen  2 , Ekkarat Wongsawat  2 , Chompunuch Boonarkart  5 , Waritta Sawaengdee  6
Affiliations

A Randomized Controlled Trial of Combined Ivermectin and Zinc Sulfate versus Combined Hydroxychloroquine, Darunavir/Ritonavir, and Zinc Sulfate among Adult Patients with Asymptomatic or Mild Coronavirus-19 Infection

Sireethorn Nimitvilai et al. J Glob Infect Dis. .

Abstract

Introduction: Ivermectin, hydroxychloroquine (HQ), and darunavir/ritonavir are widely prescribed as an oral treatment for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection despite their uncertainty of clinical benefit. The objective is to determine the safety and the efficacies of two treatment regimens against SARS-CoV-2 infection.

Methods: We conducted an open-labeled, randomized, controlled trial to compare the efficacy between a 3-day course of once-daily high-dose oral ivermectin plus zinc sulfate (Group A) and a combination of HQ, darunavir/ritonavir, and zinc sulfate (HQ + antiretroviral, Group B) for 5 days in asymptomatic or mild SARS-CoV-2 infection. The study period was between December 2020 and April 2021.

Results: Overall, 113 patients were randomized and analyzed (57 patients in Group A and 56 patients in Group B). The median duration to achieve the virological outcome of either undetected or cycle threshold (Ct) for N gene of SARS-CoV-2 by real-time polymerase chain reaction was 6 days (95% confidence interval [CI] 5.3-6.7) versus 7 days (95% CI: 5.4-8.6) in Group A and Group B, respectively (P = 0.419) in the modified intention-to-treat population. All patients were discharged from hospital quarantine as planned. Two patients in Group A and one patient in Group B were considered clinically worsening and received 10 days of favipiravir treatment. There was no serious adverse event found in both groups.

Conclusion: We demonstrated that both treatment regimens were safe, but both treatment regimens had no virological or clinical benefit. Based on this result and current data, there is no supporting evidence for the clinical benefit of ivermectin for coronavirus-19.

Keywords: Coronavirus-19; darunavir/ritonavir; hydroxychloroquine; ivermectin.

PubMed Disclaimer

Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Study flow
Figure 2
Figure 2
Modified intention-to-treat analysis: Kaplan–Meier plots of proportion of patients with undetected PCR or Ct >30 after treatment over time compared between ivermectin + Zn (A) group and HQ + ARV + Zn (B) group. PCR: Polymerase-chain reaction, HQ: Hydroxychloroquine, ARV: antiretroviral
Figure 3
Figure 3
Per-protocol analysis: Kaplan–Meier plots of proportion of patients with undetected PCR or Ct >30 after treatment over time compared between ivermectin + Zn (A) group and HQ + ARV + Zn (B) group. PCR: Polymerase-chain reaction, HQ: Hydroxychloroquine, ARV: Antiretroviral
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. N Engl J Med. 2020;382:1177–9. - PMC - PubMed
    1. Baek YJ, Lee YJ, Yoon JS, Sohn Y, Cho Y, Kim MH, et al. Duration of culturable SARS-CoV-2 within different specimens among mild and severe COVID-19 patients: A longitudinal study. J Infect. 2021;83:e29–31. - PMC - PubMed
    1. Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020;178:104787. - PMC - PubMed
    1. Momekov G, Momekova D. Ivermectin as a potential COVID-19 treatment from the pharmacokinetic point of view: Antiviral levels are not likely attainable with known dosing regimens. Biotechnol Biotechnol Equip. 2020;34:469–74.
    1. Hill A, Garratt A, Levi J, Falconer J, Ellis L, McCann K, et al. Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection. Open Forum Infect Dis. 2021;8:ofab358. - PMC - PubMed